Zaleplon 10 mg Capsules Under Non-Fasting Conditions

This study has been completed.

Sponsor:

Teva Pharmaceuticals USA

ClinicalTrials.gov Identifier:

NCT00829868

First Posted: January 27, 2009

Last Update Posted: August 18, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The objective of this study is to compare the relative bioavailability of zaleplon 10 mg capsules(manufactured and distributed by TEVA Pharmaceuticals USA) with that of SONATA® 10mg capsules (Wyeth-Ayerst Pharmaceuticals) in healthy, non-smoking, adult subjects under non-fasting conditions.

Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period

Drug: Zaleplon 10 mg Capsules

1 x 10 mg

Active Comparator: Sonata®

Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period

Drug: SONATA® 10 mg capsules

1 x 10 mg

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

non-smokers

at least 18 years of age

subjects will have a BMI (body mass index) of 30 or less

Exclusion Criteria:

Subjects with a significant recent history of chronic alcohol consumption(past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma(past 5 years), diabetes,psychosis or glaucoma will not be eligible for this study.

Subjects whose clinical laboratory test values are outside the reference range may be retested at the discretion of the clinical investigator. If the clinical values are outside the range of retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.

Subjects who have history of allergic responses to the class of drug being tested will be excluded from the study. Subjects with intolerance to alcohol or or other CNS depressants should not participate in this study.

Subjects whou use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.

All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.

Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.

Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.

Female subjects who are pregnant , breast feeding, or whi are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) of they will not be allowed to participate. Female subjects who have used hormonal oral contraceptives within 14 days of dosing or implanted or injected hormonal contraceptives within 180 days of dosing will not be allowed to participate.

All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive of inconclusive results will be withdrawn from the study.

Subjects who do not tolerate venipuncture will not be allowed to participate.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829868